Last reviewed · How we verify
NCT04600791
BATwire Implant Kit
NA trial testing BATwire Implant Kit in Heart Failure in 93 participants. Terminated before completion.
28 August 2024
Quick facts
| Lead sponsor | CVRx, Inc. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 93 |
| Start date | 29 January 2021 |
| Primary completion | 28 August 2024 |
| Estimated completion | 17 February 2025 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- BATwire Implant Kit
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
CVRx, Inc. — full company profile →
Who can join
Adults 21 to 80, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current and future use of neuromodulation in heart failure.
Duncker D, Bauersachs J. · · 2022 · cited 13× · PMID 35991620 · DOI 10.1093/eurheartjsupp/suac031
Verify or expand the search:
- PubMed search for NCT04600791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other CVRx, Inc. trials
Trials by the same sponsor.
- NCT05860348 — Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04600791 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CVRx, Inc.
- Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04600791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing